Wound care and infusion method and system utilizing a thermally-treated therapeutic agent

ABSTRACT

A combination therapy pad that includes a first layer and a second layer operatively coupled to the first layer. A fiber-optic array is disposed between the first layer and the second layer. A third layer is operatively coupled to the first layer. The third layer includes a vacuum tube in fluid communication with a vacuum source and a therapeutic fluid tube in fluid communication with a therapeutic fluid source. The third layer provides at least one of vacuum therapy and therapeutic fluid treatment to a wound area.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to, and incorporates by reference forany purpose the entire disclosure of, U.S. Provisional PatentApplication No. 61/776,328, filed Mar. 11, 2013. This applicationincorporates by reference the entire disclosure of U.S. patentapplication Ser. No. 13/359,210, filed Jan. 26, 2012, U.S. patentapplication Ser. No. 11/975,047, filed Oct. 17, 2007, U.S. patentapplication Ser. No. 11/801,662, filed May 9, 2007, U.S. patentapplication Ser. No. 10/894,369, filed Jul. 19, 2004, U.S. Pat. No.5,097,829, filed Mar. 19, 1990, U.S. Pat. No. 5,989,285, filed Aug. 15,1996, and U.S. Pat. No. 6,935,409, filed Jun. 8, 1999.

BACKGROUND OF THE INVENTION

Technical Field

The present invention relates to a wound care method and system withthermally augmented oxygenation and infusion therapy, and moreparticularly, but not by way of limitation, to a wound care systemconfigured supply infusion of a thermally-treated therapeutic agent to awound area.

Description of the Related Art

An important aspect of patient treatment is wound care. Medicalfacilities are constantly in need of advanced technology for thecleaning and treatment of skin wounds. The larger the skin wound, themore serious the issues are of wound closure and infection prevention.The rapidity of the migration over the wound of epithelial andsubcutaneous tissue adjacent the wound is thus critical. Devices havebeen developed and/or technically described which address certainaspects of such wound healing. For example, U.S. Pat. No. 6,695,823 toLina et al. (“Lina”) describes a wound therapy device that facilitateswound closure. A vacuum pump is taught for collecting fluids from thewound. WO 93/09727 discloses a solution for wound drainage by utilizingnegative pressure over the wound to promote the above referencesmigration of epithelial and subcutaneous tissue over the wound.

In other embodiments, wound treatment is performed using light therapy.For example, U.S. Pat. No. 7,081,128 to Hart et al. (“Hart”) describes amethod of treating various medical conditions such as, for example,joint inflammation, edema, etc., utilizing an array of Light EmittingDiodes contained on a flexible substrate that may be wrapped around ananatomical feature of the human body. U.S. Pat. No. 6,596,016 to Vremanet al. (“Vreman”) discloses a phototherapy garment for an infant havinga flexible backing material, a transparent liner, and a flexible printedcircuit sheet containing surface-mounted LEDs. The LEDs preferably emithigh-intensity blue light, suitable for the treatment of neonatalhyperbilirubinemia. The device may include a portable power supply.

In other embodiments, wound treatment is performed using oxygen. The useof oxygen for the treatment of skin wounds has been determined to bevery beneficial in certain medical instances. The advantages aremultitudinous and include rapidity in healing. For this reason, systemshave been designed for supplying high concentration of oxygen to woundsites to facilitate the healing process. For example, U.S. Pat. No.5,578,022 to Scherson et al. (“Scherson”) teaches an oxygen producingbandage and method. One of the benefits cited in Scherson is the abilityto modulate a supply of concentrated hyperbaric oxygen to skin wounds.Although oxygen is beneficial in direct application of predetermineddosages to skin wounds, too much oxygen can be problematic. Oxygenapplied to a wound site can induce the growth of blood vessels forstimulating the growth of new skin. Too much oxygen, however, can leadto toxic effects and the cessation of healing of the wound. It would bean advantage, therefore, to maximize the effectiveness of oxygen appliedto a wound area by enhancing the absorption rate of oxygen into the skinand tissue fluids. By enhancing the absorption rate of the oxygen in thewound, less exposure time and concomitantly fewer toxic side effects tothe endothelial cells surrounding the wound, such as devasculation,occurs. It would be a further advantage, therefore, to utilize existingmedical treatment modalities directed toward other aspects of patienttherapy to augment oxygenation for wound care.

It has been accepted for many years by medical care providers thatpatient thermal therapy can be very advantageous for certain injuriesand/or post operative recovery. For this reason, thermal therapy hasbeen advanced and many reliable and efficient systems exist today whichprovide localized thermal therapy to patients in both pre and postsurgical environments. In particular, absorption of oxygen by cells isenhanced by contrast thermal therapy wherein the wound area is heatedprior to being saturated with oxygen and subsequently cooled.

Addressing first thermal therapy systems, several devices have beenengineered to deliver temperature controlled fluids through pads orconvective thermal blankets to achieve the above purpose. Typically,these devices have a heating or a cooling element, a source for thefluid, a pump for forcing the fluid through the pad or blanket, and athermal interface between the patient and the temperature controlledfluid. U.S. Pat. No. 4,884,304 to Elkins (“Elkins”) is, for example,directed to a mattress cover device which contains liquid flow channelswhich provide the selective heating or cooling by conduction.

Devices have also been developed for simply providing heat or cooling toa person in bed. Electric blankets containing electric heating elementshave been used, for example, to provide heat to people in bed. Likewise,cooling blankets, such as the blanket disclosed in U.S. Pat. No.4,660,388 to Greene (“Greene”), have also been proposed. Greenediscloses a cooling cover having an inflatable pad with plenum chambersat opposite ends thereof. Cool air is generated in a separate unit anddirected to the pad and out to a number of apertures on the underside ofthe pad and against the body of the person using the cover.

A disposable heating or cooling blanket is disclosed in U.S. Pat. No.5,125,238 to Ragan et al. (“Ragan”), which has three layers of flexiblesheeting. Two of the layers form an air chamber while a third layerincludes a comfortable layer for contact with the patient. Conditionedair is directed toward the covered person through a multiplicity oforifices in the bottom layers of the blanket.

A temperature controlled blanket and bedding assembly is also disclosedin U.S. Pat. No. 5,989,285 to DeVilbiss et al. (“DeVilbiss”), assignedto the assignee of the present invention. DeVilbiss discloses atemperature controlled blanket and temperature control bedding systemhaving the provision of both recirculating temperature controlled fluidand temperature controlled gas to enhance performance for convectivelyheating or cooling a patient. Counter-flow or co-flow heat exchangingprinciples between the temperature controlled liquid and the temperaturecontrolled gas achieve temperature uniformity across different sectionsof the blanket and the bedding system. Drapes and the temperaturecontrolled bedding system provide a temperature controlled envelopearound a person using the bedding system. In one embodiment of thebedding system, the air portion of the bedding system is provided foruse with a patient that supplies the fluid portion of the overallbedding system. In another embodiment of the bedding system, the fluidportion of the bedding system is provided for use with a patient bedwhich supplies the air portion of the overall bedding system.

U.S. Pat. No. 5,097,829 to Quisenberry (“Quisenberry”) describes animproved temperature controlled fluid circulating system forautomatically cooling a temperature controlled fluid in a thermalblanket with a thermoelectric cooling device having a cold side and ahot side when powered by electricity. The temperature controlled fluidis cooled by the cold side of the cooling device and pumped through, to,and from the blanket through first and second conduits.

Finally, co-pending U.S. patent application Ser. No. 10/894,369,assigned to the assignee of the present invention, teaches a sequentialcompression blanket for use with heating or cooling therapy. In thisparticular embodiment, the utilization of thermal therapy withsequential compression in a programmable format which further has theoption of the introduction of oxygenation through a perforated membranedisposed between the patient and the thermal therapy pad is taught.These advances in the medical industry have been recognized asadvantageous to both the medical care providers as well as the patients.The precise manner of oxygenation application is, however, still in theprocess of development.

The present invention provides improvements in wound care by providingmultiple wound healing approaches such as, for example, the applicationof negative pressure over the wound area along with light therapy of thewound area, and oxygenation of the wound area in conjunction withthermal therapy. By combining an oxygenation modality that is utilizedin conjunction with light and thermal therapy and/or sequentialcompression in association therewith, the individual benefits ofnegative wound pressure, light therapy, and oxygenation treatments canbe synergistically enhanced.

SUMMARY

The present invention relates to a wound care method and system with oneor both of vacuum-light therapy, pulsed radio frequency (“RF”), infusiontherapy, and thermally augmented oxygenation, and more particularly, butnot by way of limitation, to a wound care system configured supplyinfusion of a thermally-treated therapeutic agent to a wound area. Inone aspect, the present invention relates to a method of treating awound area. The method includes introducing a therapeutic agent to intoan infusion tube associated with a patch. A temperature of thetherapeutic agent is adjusted and the therapeutic agent is pushed to thepatch. The therapeutic agent is allowed to soak on the wound area for apre-determined period of time. The therapeutic agent is removed from thewound area via vacuum pressure supplied by a vacuum pump.

In another aspect, the present invention relates to a wound-care system.The wound-care system includes a patch. An infusion tube is coupled tothe patch and an oxygen concentrator is coupled to the patch via theinfusion tube. A vacuum tube is coupled to the patch and a pump iscoupled to the patch via the vacuum tube. The wound-care system furtherincludes a reservoir containing a therapeutic agent. The reservoir isfluidly coupled to the infusion tube. A temperature control is fluidlycoupled to the reservoir. The temperature control adjusts a temperatureof the therapeutic agent. A first plurality of solenoids are disposedbetween the patch and at least one of the reservoir and the oxygenconcentrator. A second plurality of solenoids are disposed between thepump and the patch.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the method and apparatus of the presentinvention may be obtained by reference to the following DetailedDescription when taken in conjunction with the accompanying Drawingswherein:

FIG. 1 is an illustration of the wound care system according to anexemplary embodiment;

FIG. 2 is a block diagram according to an exemplary embodiment;

FIG. 3 is a flow diagram of a process according to an exemplaryembodiment;

FIG. 4 illustrates a side elevational cross sectional view of a therapyblanket/pad according to an exemplary embodiment;

FIG. 5 illustrates a side elevational cross sectional view of a therapyblanket/pad according to an exemplary embodiment;

FIG. 6 is a diagrammatic illustration of a therapy blanket/pad accordingto an exemplary embodiment;

FIG. 7 is a diagrammatic illustration of a wound evacuation and UV LEDtreatment pad according to an exemplary embodiment;

FIG. 8A is a schematic diagram of a wound care system according to anexemplary embodiment;

FIG. 8B is a front perspective view of a wound care system according toan exemplary embodiment;

FIG. 8C is a front perspective view of a wound care system illustratinga plurality of hooks according to an exemplary embodiment;

FIG. 9 is a is a block diagram of a wound care system according to anexemplary embodiment;

FIG. 10 is a block diagram of a wound care system according to anexemplary embodiment;

FIG. 11 is a diagrammatic illustration of a combination therapy padaccording to an exemplary embodiment;

FIG. 12 is a diagrammatic illustration of a combination therapy padaccording to an exemplary embodiment;

FIG. 13 is an exploded view of a combination therapy pad according to anexemplary embodiment;

FIG. 14 is a schematic diagram of a wound-infusion system according toan exemplary embodiment; and

FIG. 15 is a flow diagram of a process for administering infusiontherapy in conjunction with vacuum therapy and oxygenation therapyaccording to an exemplary embodiment.

DETAILED DESCRIPTION

Various embodiments of the present invention will now be described morefully with reference to the accompanying drawings. The invention may,however, be embodied in many different forms and should not be construedas limited to the embodiments set forth herein; rather, the embodimentsare provided so that this disclosure will be thorough and complete, andwill fully convey the scope of the invention to those skilled in theart.

Referring first to FIG. 1, there is shown an illustration of oneembodiment of a wound care system 10 in accordance with principles ofthe present invention. The system 10 comprises a control unit 12, atherapy blanket/pad 14 and a plurality of tubular members 16 (to bedefined below) connecting the control unit 12 to the therapy blanket/pad14. The system 10 further includes a wound evacuation and ultra violetlight emitting diode (UV LED) unit 28 and a wound evacuation and UV LEDtreatment pad 58. The wound evacuation and UV LED unit 28 is connectedto the control unit 12 while the wound evacuation and UV LED treatmentpad 58 is connected to the wound evacuation and UV LED unit 28. A systemfor providing both oxygenation therapy in conjunction with certainaspects of thermal therapy and fully describing the thermal operationand sequence compression aspects of one embodiment of the presentinvention is set forth and shown in U.S. patent application Ser. No.10/894,369, assigned to the assignee of the present invention andincorporated herein in its entirety by reference. For that reason,thermal detail relative to the interaction between the control unit 12and the therapy blanket/pad 14 relative to the thermal fluid flow andpressurization for sequenced compression therapy is not further definedherein. What is defined, is the added aspect of wound care provided bywound evacuation and light therapy. Light therapy is the application oflight energy to the skin for therapeutic benefits. LED light therapypromotes wound healing and human tissue growth. Energy delivered by theLEDs enhances cellular metabolism, accelerates the repair andreplenishment of damaged skin cells, as well as stimulates theproduction of collagen which is the foundation of a healthy and smoothskin. Light therapy is non-ablative, non-invasive, and painless.

Still referring to FIG. 1, the use of the therapy blanket/pad 14 to thewound site of the patient may be, in one embodiment, subsequent to thecleaning of the wound area of dead tissue by the wound evacuation and UVLED treatment pad 58. In one embodiment, Velcro cross straps may beutilized to secure the therapy blanket/pad 14. A 93% concentration ofoxygen has been suggested to be advantageous when applied to a woundsite as described herein with one or two atmospheres of pressure. Inaccordance with one aspect of the present invention, an oxygengenerator/concentrator 20 may be utilized within the control unit 12 ormay be separate therefrom. In FIG. 1, an oxygen generator/concentrator20 is shown in association with the control unit 12 by dotted line 22and an oxygenation gas line 24 shown extending between the control unit12 and the therapy blanket/pad 14 as a diagrammatic illustrationaccording to an embodiment of the present invention.

In FIG. 1, fiber optic strands (not explicitly shown) direct ultravioletlight from a plurality of LEDs (not explicitly shown) to an array offiber optic strand ends (not explicitly shown) located on theundersurface of wound evacuation and UV LED treatment pad 58. Thecontrol unit 12 may be used to modulate the ultraviolet light to createvarious patterns of light, different intensities of light, and differentdurations of light. For example, the control unit 12 may be used togenerate pulsed emission of ultraviolet light. The ultraviolet light iscapable of penetrating through several layers of skin to destroyinfectious bacteria. In one embodiment, not specifically shown herein,the UV LED treatment pad 58 may be provided on the therapy blanket/pad14. According to exemplary embodiments, the ultraviolet light from theplurality of LEDs located on the undersurface of wound evacuation and UVLED treatment pad 58 destroys a wide variety of microorganisms such as,for example, bacteria which causes skin infections. In addition, theultraviolet light from the plurality of LEDs improves wound healingalong with cell and bone growth. Furthermore, the use of LEDs in lighttherapy is safe, non-invasive, drug-free and therapeutic.

Referring now to FIG. 2, there is a block diagram 200 illustrating theflow of oxygenation gas as a transfer fluid according to an embodimentof the present invention. As set forth in the block diagram 200, acontrol unit display 30 is provided in conjunction with ananalog/digital processing unit 32. A plurality of sensors 34 areutilized in conjunction with the processing unit 32 for control of heattransfer fluids to the therapy blanket/pad 14 as well as the oxygendelivery thereto. The oxygen generator/concentrator 20 is connected to apower supply 36, which power supply 36, also powers the processing unit32. The oxygen generated from the oxygen generator/concentrator 20 isthen pumped through compression pump 38 before delivery to the therapyblanket/pad 14. It should be noted that an oxygen supply may also beused.

Referring still to FIG. 2, a water/alcohol reservoir 40 is shown influid flow communication with fluid pump 42 and Thermo Electric Cooler(TEC) heater/cooler 44. The TEC heater/cooler 44 is controlled by theprocessing unit 32 and a TEC supply 46 is likewise shown. Adjacent theTEC supply 46 is illustrated a diagrammatical schematic of a treatmentchamber 50 defined beneath the therapy blanket/pad 14 wherein thetreatment chamber 50 is thermally exposed to the thermal fluid by thefluid path therein illustrated. The adhesive attachment edges 52 thereinshown likewise define the treatment chamber space 50 between the therapyblanket/pad 14 and the wound site to allow for the flow of theoxygenation gas therein.

Referring still to FIG. 2, there is shown a vacuum pump 59 powered bythe power supply 36. A collection chamber 56 is connected to the vacuumpump 59 and to a wound evacuation and UV LED treatment pad 58. The woundevacuation and UV LED treatment pad 58 is used prior to the therapyblanket/pad 14, in one embodiment of the present invention, for cleaningthe wound area in preparation for oxygenation in conjunction withthermal therapy in accordance with the present invention.

Referring still to FIG. 2, there is shown a plurality of ultravioletLEDs 60 and fiber optic strands 62, which are interoperably connected tothe wound evacuation and UV LED treatment pad 58. The wound evacuationand UV LED treatment pad 58 is used prior to the therapy blanket/pad 14,in one embodiment of the present invention, for removing bacteria fromthe wound area in preparation for oxygenation in conjunction withthermal therapy in accordance with an embodiment. According to exemplaryembodiments, ultraviolet light from the plurality of LEDs 60 destroys awide variety of microorganisms such as, for example, bacteria whichcauses skin infections. In addition, the ultraviolet light from theplurality of LEDs 60 improves wound healing along with cell and bonegrowth. Furthermore, the use of the plurality of LEDs 60 in lighttherapy is safe, non-invasive, drug-free and therapeutic.

According to exemplary embodiments, the ultraviolet light from theplurality of LEDs 60 is in the range of approximately 200 to 450nanometers and higher, and energy levels of up to 35,000 microwattseconds/cm², which are necessary to eliminate or destroy mostmicroorganisms such as bacteria, spores, algae and viruses. Mostbacteria can be destroyed at ultra violet energies of from about 3,000to about 5,000 microwatt-seconds/cm² while mold spores may requireenergies in the 20,000 to 35,000 mW-seconds/cm².

Referring now to FIG. 3 there is shown a flow diagram of a process 300according to an embodiment. The process 300 starts at step 101. At step102, the wound area is cleaned of dead tissue, any undesirable fluids,and bacteria by applying the wound evacuation and UV LED treatment pad58. The wound evacuation and UV LED treatment pad 58 is used prior tothe therapy blanket/pad 14 for removing bacteria from the wound area inpreparation for oxygenation in conjunction with thermal therapy inaccordance with the present invention. According to exemplaryembodiments, the ultraviolet light from the plurality of LEDs located onthe undersurface of wound evacuation and UV LED treatment pad 58destroys a wide variety of microorganisms such as, for example, bacteriawhich causes skin infections. In addition, the ultraviolet light fromthe plurality of LEDs improves wound healing along with cell and bonegrowth. Furthermore, the use of LEDs in light therapy is safe,non-invasive, drug-free and therapeutic.

At step 103, the therapy blanket/pad 14 is applied to the wound area.The therapy blanket/pad 14 is held in position by an adhesive borderand, in one embodiment, elastic Velcro cross straps. At step 104,according to an embodiment, an oxygenation gas comprising on the orderof 93% concentration of oxygen gas is delivered to the wound site withone to two atmospheric pressures. The numbers as set forth and shown areexemplary and other oxygenation concentrations as well as pressures arecontemplated in various embodiments. Consistent therewith, however, isthe concept of, and teachings for, thermal treatment of the wound sitein conjunction with oxygenation. In step 106, the site is warmed throughthe fluid path herein shown on the back side of the therapy blanket/pad14 up to approximately 5 to approximately 6 degrees above the bodytemperature of the patient. Warming allows the pores of the patient'sskin to open, exposing capillaries therein. The capillaries of the skinare then saturated with oxygen. In one period of time herein described,a warming period of approximately 15 to approximately 30 minutes isrecommended. At step 108, oxygenation is continued at one to twoatmospheres and the therapy blanket/pad fluid is lowered toapproximately 30 to approximately 40 degrees below body temperatures.Cooling closes the pores of the wound area and pulls oxygen into theunderlying tissue. Cooling then proceeds for approximately 30 toapproximately 45 minutes in accordance with an embodiment. At step 110,the process 300 may be repeated periodically and the wound area may becleaned of dead tissue before each treatment. At step 112, the process300 ends.

FIG. 4 is a side elevational, cross sectional view of one embodiment ofthe therapy blanket/pad 14. In an embodiment, the therapy blanket/pad 14is constructed with a single bladder 114 where thermal fluid flow may beprovided. The tubular members 16 are coupled to the therapy blanket/pad14. The therapy blanket/pad is fabricated with a circuitous flow paththerein for thermal fluid flow. The circuitous flow path may be tubularin form, or simply a path within therapy blanket/pad 14 defined by flowchannels. What is shown is a path 117 within therapy blanket/pad 14. Thepath 117 is shown with tubular ends 117A, for example, illustrating thatthermal fluid flows therein for thermal treatment of the underlyingwound area. Again, the path 117 may not be of tubular form and may havea variety of shapes and fabrication techniques well known in the art ofthermal pads.

According to an exemplary embodiment, the therapy blanket/pad 14 isseparated from the patient's skin by adhesive strips 119 having athickness of, for example, ⅛ inch. The therapy blanket/pad 14 (not drawnto scale) exposes the wound to both heat and cold via the path 117 whileoxygen is injected into the treatment chamber 50. The injection ofoxygen in conjunction with the aforesaid heating and cooling via thepath 117 helps treat the wound area and any stasis zones therein wheretissue swelling has restricted flow of blood to tissues within the woundarea. It is well known that, without sufficient blood flow, theepithelial and subcutaneous tissues referenced above receive less oxygenand are less able to migrate over the wound area to promote healing. Byutilizing the embodiments disclosed herein, oxygenation is enhanced andthe problems associated with such conditions are mitigated.

FIG. 5 illustrates an exemplary embodiment of the thermal therapy andoxygenation treatment pad of FIG. 4. A dual bladder 214 is thus providedwhere air may be applied to second bladder 207 atop the path 117, alsorepresented by the “tubular” ends 117A shown for purposes of exampleonly. In this manner, select compression therapy may be afforded inconjunction with the thermal and oxygenation treatment. In that regard,air inlet tube 201 is connected to the second bladder 207. Both FIGS. 4and 5 show oxygen tube 24 for feeding oxygen to the treatment chamber50, with tube 203 allowing thermal fluid into conduits 117 with tube 205allowing thermal fluid return to control unit 12 of FIG. 1. FIG. 5further illustrates the advantages of FIG. 4 with the ability for eithercompression or sequenced compression as referenced above.

Referring now to FIG. 6, there is shown a diagrammatic illustration ofthe therapy blanket/pad 14 of FIGS. 1 and 4. The tubular members 16 forthermal fluid flow and the tube 24 for oxygen flow are clearly seen. Theadhesive border 119 is likewise shown.

FIG. 7 is diagrammatic illustration of a wound evacuation and UV LEDtreatment pad 58 according to an embodiment of the present invention. Inthis embodiment, the wound evacuation and UV LED treatment pad 58contains an array of fiber optic strand 72 to project ultraviolet lightonto a wound area (not explicitly shown). In a typical embodiment, thefiber optic strands 72 may be cleaved side emitting fibers. The woundevacuation and UV LED treatment pad 58 also contains an array of uniqueremoval ports 57 that may be used to remove any undesirable fluid fromthe wound area. The wound evacuation and UV LED treatment pad 58 furthercontains a non-tissue adhesive service 80 which contains both the fiberoptic strand array 72 and the unique removal ports 57. An adhesivecircumference 82 is located around the periphery of the wound evacuationand UV LED treatment pad 58 to allow for a seal to be formed around thewound area. The seal, in conjunction with the removal ports 57, allows anegative pressure to form over the wound area. Negative pressurefacilitates removal undesirable tissues from the wound area. The woundevacuation and UV LED treatment pad 58 is connected to a control unit12. The control unit 12 contains a vacuum pump (not shown) and aplurality of ultraviolet LEDs (not explicitly shown). The vacuum pump isconnected to the wound evacuation and UV LED treatment pad 58 via avacuum line 55. A collection chamber 56 is positioned between the vacuumpump and the wound evacuation and UV LED treatment pad 58 to interceptand store undesirable fluids, tissues, and the like that are removedfrom the wound area as a result of negative pressure applied to thewound area with the vacuum pump. The plurality of ultraviolet LEDstransmit ultraviolet light through the fiber optic strands 70 to thewound evacuation and UV LED treatment pad 58, where the fiber opticstrands 70 are then dispersed throughout the wound evacuation and UV LEDtreatment pad 58 to project ultraviolet light onto the wound area.Energy delivered by the plurality of LEDs enhances cellular metabolism,accelerates repair and replenishment of damaged skin cells, as well asstimulates production of collagen which is the foundation of a healthyand smooth skin. Light therapy is non-ablative, non-invasive, andpainless.

FIG. 8A is a schematic diagram of a wound care system according to anexemplary embodiment. A wound care system 800 includes a control unit802, a combination therapy pad 804, and a plurality of tubular members806 connecting the combination therapy pad 804 to the control unit 802.A wound evacuation and UV-LED unit 808 is associated with the controlunit 802 and connected to the combination therapy pad 804. In variousembodiments, the wound evacuation and UV-LED unit 808 and the controlunit 802 are contained in a single housing; however, in variousalternative embodiments, the wound evacuation and UV-LED unit 808 andthe control unit 802 may not be in a single housing and are independentdevices.

Still referring to FIG. 8A, use of the combination therapy pad 804incorporates ultraviolet light and evacuation therapy for wound cleaningwith thermal and oxygenation therapy known to promote healing. Invarious embodiments, Velcro cross straps are used to secure thecombination therapy pad 804. An oxygen generator/concentrator 810 isutilized to provide, for example, a 93% concentration of oxygen to awound site via the combination therapy pad 804. In a typical embodiment,the oxygen generator/concentrator 810 and the control unit 802 areseparate devices; however, in other embodiments, the oxygengenerator/concentrator 810 and the control unit 802 are contained in asingle housing.

Still referring to FIG. 8A, fiber optic strands (not explicitly shown)direct ultraviolet light from a plurality of LEDs (not explicitly shown)located in the wound evacuation and UV-LED unit 808 to an array of fiberoptic strands (not explicitly shown) located on an undersurface of thecombination therapy pad 804. The control unit 802 may be used tomodulate the ultraviolet light to create, for example, various patternsof light, different intensities of light, and different durations oflight. For example, in various embodiments, the control unit 802 is usedto produce pulsed emission of the ultraviolet light.

FIG. 8B is a front perspective view of a wound care system according toan exemplary embodiment. The wound care system 800 includes the controlunit 802, the combination therapy pad 804, and the plurality of tubularmembers 806 connecting the combination therapy pad 804 to the controlunit 802. A user interface 805 is disposed on a front surface of thecontrol unit 802. In a typical embodiment, the user interface 805 allowsa user to control various parameters of wound care-treatment including,for example, oxygen concentration, oxygen pressure, temperature, andultra-violet light intensity. The user interface 805 may be pivotedrelative to the control unit 802 to provide a favorable viewing angle.In a typical embodiment, the user interface 805 may be, for example atouch screen interface; however, in other embodiments, the userinterface 805 may be, for example, a plurality of controls or any otheruser interface. Use of the combination therapy pad 804 incorporatesultraviolet light and evacuation therapies for wound cleaning withthermal and oxygenation therapy known to promote healing. In variousembodiments, Velcro cross straps (not shown) may be used to secure thecombination therapy pad 804.

FIG. 8C is a front perspective view of the wound care system of FIG. 8Aillustrating a plurality of foldable hooks. The wound care system 800includes a plurality of foldable hooks 803 disposed, for example, alonga top of the control unit 802. In a typical embodiment, the plurality offoldable hooks 803 may be utilized to hang the control unit 802 from,for example, a hospital bed.

FIG. 9 is a block diagram of a wound care system according to anexemplary embodiment. In a wound-care system 900, a control unit display902 is provided in conjunction with a processing unit 904. In a typicalembodiment, the processing unit 904 is an analog/digital processingunit. A plurality of sensors 906 are utilized in conjunction with theprocessing unit 904 for control of heat transfer fluids to a combinationtherapy pad 804. In various embodiments, the oxygengenerator/concentrator 810 is connected to a power supply 908. The powersupply 908 also powers the processing unit 904. Oxygen generated by theoxygen generator/concentrator 810 is pumped through a compression pump910 and a pressure switch 921 before being delivered to the combinationtherapy pad 804.

Still referring to FIG. 9, in a typical embodiment, a water/alcoholreservoir 912 is in fluid communication with a fluid pump 914 and athermoelectric cooler 916. The thermoelectric cooler 916 is controlledby the processing unit 904. In a typical embodiment, a vacuum pump 918is powered by the power supply 908. A collection chamber 920 is fluidlyconnected to the vacuum pump 918 and the pressure switch 921. Thepressure switch 921 is fluidly coupled to the combination therapy pad804. In a typical embodiment, oxygen therapy and vacuum therapy are eachadministered to the combination therapy pad 804 through a common port922. In a typical embodiment, the pressure switch 921 is capable ofadjusting the combination therapy pad 804 between vacuum treatment andoxygenation therapy.

FIG. 10 is a block diagram of a wound care system according to anexemplary embodiment. In a typical embodiment, a wound care system 1000is similar in construction to the arrangement described above withrespect to FIG. 9. However, the wound care system 1000 does not includea water/alcohol reservoir or a fluid pump as shown in FIG. 9. In atypical embodiment, the thermoelectric cooler 916 is in fluidcommunication with the compression pump 910. Thus, thermal therapy issupplied to the combination therapy pad 804 through heating and coolingof the oxygen supplied by the oxygen generator/concentrator 810.

FIG. 11 is a diagrammatic illustration of a combination therapy padaccording to an exemplary embodiment. In a typical embodiment, thecombination therapy pad 804 includes a plurality of fiber optic strands72 to project ultraviolet light onto a wound area (not explicitlyshown). In various embodiments, the fiber optic strands 72 may becleaved or side-emitting fibers; however, one skilled in the art willrecognize that any type of fiber-optic strand could be used. In atypical embodiment, the combination therapy pad 804 also includes aplurality of oxygenation/removal ports 1102. In a typical embodiment,the oxygenation/removal ports 1102 alternate between providing oxygentherapy and vacuum therapy to the wound area.

Still referring to FIG. 11, in a typical embodiment, oxygen therapy andvacuum therapy is administered to the combination therapy pad 804 via anevacuation/oxygenation line 1104. The evacuation/oxygenation line 1104is fluidly coupled to the pressure switch 921. The pressure switch 921is fluidly connected to the compression pump 910 and the vacuum pump918. Thus, in a typical embodiment, the pressure switch 921 is capableof adjusting the combination therapy pad 804 between vacuum treatmentand oxygenation therapy.

Still referring to FIG. 11, in various embodiments, a luer lock 1106 isfluidly coupled to the combination therapy pad 804. During treatment, itis often necessary to administer various medications to a wound site.Such administration often requires removal of a wound dressing such as,for example, the combination therapy pad 804. Frequent removal of thewound dressing can increase risk of further damage to tissue immediatelysurrounding the wound site. In a typical embodiment, the luer lock 1106allows for administration of medications and other therapeutic compoundsdirectly to a wound site without the need to remove the combinationtherapy pad 804.

FIG. 12 is a diagrammatic illustration of a combination therapy padaccording to an exemplary embodiment. In a typical embodiment, thecombination therapy pad 1200 includes the plurality of fiber opticstrands 72 to project ultraviolet light onto a wound area (notexplicitly shown). In a typical embodiment, a combination therapy pad1200 also includes a radio frequency (“RF”) antenna 1202. In a typicalembodiment, the RF antenna 1202 comprises a wire 1204. The wire 1204extends along a length of the combination therapy pad 1204. In a typicalembodiment, the wire 1204 is disposed within the combination therapy pad1200 so that, during use, the wire is in close proximity to a woundarea. In various embodiments, the wire 1204 is insulated to reduce riskof electric shock to a patient.

FIG. 13 is an exploded view of a combination therapy pad according to anexemplary embodiment. A combination therapy pad 1300 includes a firstlayer 1302 having a first central gap 1304 formed therein. In a typicalembodiment, the first layer 1302 is constructed of, for example,urethane. A second layer 1305 is disposed below the first layer 1302 andincludes an adhesive bottom surface 1306. A second central gap (notexplicitly shown) is formed in the second layer 1305 In a typicalembodiment, the second layer 1305 is constructed of, for example,urethane. The first layer 1302 and the second layer 1305 are coupled toeach other around a perimeter of the first layer 1302 and the secondlayer 1305 so that the second central gap aligns with the first centralgap 1304. A fiber-optic array 1308 is disposed between the first layer1302 and the second layer 1305 so as to fill a space defined by thefirst central gap 1304 and the second central gap.

Still referring to FIG. 13, a third layer 1310 is disposed above thefirst layer 1302. The third layer 1310 includes a recessed central area1312. The recessed central area 1312 is fluidly coupled to a vacuum tube1314 via a first port and a therapeutic fluid tube 1316 via a secondport. An antenna 1318 is coupled to the third layer 1310. The antenna1318 is formed into a loop and is generally arranged around a perimeterof the recessed central area 1312. In a typical embodiment, the firstlayer 1302, the second layer 1305, and the third layer 1310 are coupledto each other via a process such as, for example, adhesive bonding orwelding.

Still referring to FIG. 13, during operation, the adhesive bottomsurface 1306 is placed on a bodily region of a patient proximate a woundarea. In a typical embodiment, the adhesive bottom surface 1306 isoriented such that the second central gap is positioned over the woundarea. Thus, the adhesive bottom surface 1306 is not in direct contactwith the wound area. The fiber-optic array 1308 is disposed over thewound area and, in various embodiments, may contact the wound area. Thefiber-optic array 1308 delivers UV lighting to the wound area therebypromoting cleaning and disinfection of the wound area. The vacuum tube1314 applies negative pressure to the wound area thereby removingundesirable fluids, tissues, and the like from the wound area. Thetherapeutic fluid tube 1316 provides a therapeutic fluid such as, forexample, oxygen to the wound area. In various embodiments, thetherapeutic fluid may be heated or cooled prior to delivery to the woundarea. Heating or cooling of the therapeutic fluid allows delivery ofthermal therapy to the wound area.

Still referring to FIG. 13, during operation, a pulsed radio-frequency(“RF”) signal having a pulse frequency on the order of, for example 27MHz, is transmitted to the antenna 1318. In a typical embodiment, anamplitude of the pulsed RF signal is on the order of, for example, afraction of a Watt. Such an amplitude is below a threshold where federallicensing is typically required. The antenna 1318 receives the pulsed RFsignal from a radio-frequency source and transmits the pulsed RF signalto a region in close proximity to the wound area. Exposing the woundarea to the pulsed RF signal has been shown to be beneficial to healingby encouraging intracellular communication. In particular, pulsed RFsignals have been shown to stimulate cellular bonding, and metabolism.

FIG. 14 is a schematic diagram of a wound-infusion system according toan exemplary embodiment. The wound-infusion system 1400 includes acontroller 1401 having a first disconnect 1403 and a second disconnect1405. The first disconnect 1403 is fluidly coupled to an oxygenconcentrator 1416 and the second disconnect 1405 is fluidly coupled to apump 1414. A patch 1402 includes an infusion tube 1408 and a vacuum tube1410. The infusion tube 1408 is fluidly coupled to the first disconnect1403 and the vacuum tube 1410 is fluidly coupled to the seconddisconnect 1405. Thus, in operation, vacuum pressure, generated by thepump 1414, is applied to the patch 1402 via the second disconnect 1405and the vacuum tube 1410. Similarly, oxygen, supplied by the oxygenconcentrator 1416, is applied to the patch 1402 via the first disconnect1403 and the infusion tube 1408.

Still referring to FIG. 14, a reservoir 1404 is provided with the patch1402. In a typical embodiment, the reservoir contains a therapeuticagent such as, for example, saline. The reservoir 1404 is fluidlycoupled to the infusion tube 1408 via an infusion solenoid 1426 and atemperature control 1406. In a typical embodiment, the infusion solenoid1426, when open, fluidly couples the reservoir 1404 to the patch 1402via the infusion tube 1408. Thus, oxygen, supplied by the oxygenconcentrator 1416, pushes the therapeutic agent through the infusiontube 1408 to the patch 1402. When closed, the infusion solenoid 1426isolates the reservoir 1404 from the infusion tube 1408 and the patch1402. In a typical embodiment, the temperature control 1406 regulates atemperature of the therapeutic agent thereby facilitating application ofthermal therapy to a wound area (not shown) via the patch 1402. Forexample, in an exemplary embodiment, the temperature control 1406 raisesthe temperature of the therapeutic agent to a level above a bodytemperature of a patient. An exudate bottle 1412 is fluidly coupled tothe vacuum tube 1410. During operation, the exudate bottle 1412 collectsfluids and materials removed through the patch 1402 by operation ofvacuum pressure supplied by the pump 1414. Thus, the pump 1414 remainssterile during operation.

Still referring to FIG. 14, an oxygen solenoid 1424 is disposed withinthe controller 1401 and is fluidly coupled to the oxygen concentrator1416 and the first disconnect 1403. When open, the oxygen solenoid 1424fluidly couples the oxygen concentrator 1416 to the first disconnect1403. When closed, the oxygen solenoid 1424 isolates the oxygenconcentrator 1416. An oxygen vent 1430 is fluidly coupled to oxygenconcentrator 1416, the oxygen solenoid 1424, the first disconnect 1403and an exterior environment. During operation, the oxygen vent 1430allows oxygen supplied by the oxygen concentrator 1416 to be vented tothe exterior environment. An oxygen-vent solenoid 1428 is fluidlycoupled to the oxygen vent 1430. When open, the oxygen-vent solenoid1428 allows oxygen supplied by the oxygen concentrator 1416 to be ventedto the exterior environment. When closed, the oxygen-vent solenoid 1428prevents oxygen supplied by the oxygen concentrator 1416 from beingvented to the exterior environment. In a typical embodiment, the oxygensupplied by the concentrator is in the range of approximately 75% toapproximately 100% oxygen.

Still referring to FIG. 14, a pump solenoid 1418 is disposed within thecontroller 1401 and fluidly coupled to the pump 1414 and the seconddisconnect 1405. When open, the pump solenoid 1418 fluidly couples thepump 1414 to the second disconnect 1405. When closed, the pump solenoid1418 isolates the pump 1414. A vacuum vent 1432 is fluidly coupled topump 1414, the pump solenoid 1418, the second disconnect 1405 and anexterior environment. During operation, the vacuum vent 1432 allowspressure generated by the pump 1414 to be vented to the exteriorenvironment. A vacuum-vent solenoid 1422 is fluidly coupled to thevacuum vent 1432. When open, the vacuum-vent solenoid 1422 allowspressure generated by the pump 1414 to be vented to the exteriorenvironment. When closed, the vacuum-vent solenoid 1422 preventspressure generated by the pump 1414 from being vented to the exteriorenvironment. A patch solenoid 1420 is fluidly coupled to the pump 1414between the vacuum vent 1432 and the second disconnect 1405. When open,the patch solenoid 1420 fluidly couples the second disconnect 1405 tothe pump 1414. When closed, the patch solenoid 1420 isolates the seconddisconnect 1405 and the patch 1402. The patch solenoid 1420, when closedfacilitates testing of the patch 1402 to ensure a proper seal with thewound area (not shown).

FIG. 15 is a flow diagram of a process for administering infusiontherapy in conjunction with vacuum therapy and oxygenation therapyaccording to an exemplary embodiment. A process 1500 begins at step1502. At step 1504, a therapeutic agent such as, for example, saline,any wound-treating drugs, antibiotics, or any combination thereof isadministered to a wound area via the patch 1402. Vacuum pressure is alsoadministered to the wound area via the patch 1402. In a typicalembodiment, the vacuum pressure is in the range of approximately 0 mmHgto approximately 150 mmHg. During step 1504, the temperature control1406 regulates the temperature of the therapeutic agent to achieve atherapeutically-beneficial temperature. In a typical embodiment, thetherapeutically-beneficial temperature is in the range of ambienttemperature to approximately 105° F. In a typical embodiment, step 1504has a duration of approximately 10 seconds. At step 1506, the pump 1414is turned off and the pump solenoid 1418 is closed. The therapeuticagent continues to be administered to the wound area via the patch 1402.In a typical embodiment, step 1506 has a duration of approximately 10seconds. At step 1508, the oxygen-vent solenoid 1428 is opened allowingoxygen supplied by the oxygen concentrator 1416 to be vented to theexterior environment. In a typical embodiment, step 1508 has a durationof approximately 5 seconds. At step 1510, the patch solenoid 1420 andthe infusion solenoid 1428 are closed while the vacuum vent solenoid1422 and the oxygen vent solenoid 1424 are opened. In a typicalembodiment, step 1510 has a duration of approximately 20 seconds. Atstep 1512, the vacuum vent solenoid 1422 and the oxygen vent solenoid1424 are closed. In a typical embodiment, step 1512 has a duration ofapproximately 15 minutes to approximately 16 minutes. At step 1514, thepump solenoid 1418, the patch solenoid 1420, the oxygen vent solenoid1428 are opened thereby allowing the wound area to be flushed. In atypical embodiment, step 1514 has a duration of approximately 30seconds. The process ends at step 1516.

The previous Detailed Description is of embodiment(s) of the invention.The scope of the invention should not necessarily be limited by thisDescription. The scope of the invention is instead defined by thefollowing claims and the equivalents thereof.

What is claimed is:
 1. A method of treating a wound area, the methodcomprising: providing oxygen to a patch via an oxygen concentratorcoupled to an infusion tube; providing a therapeutic agent in areservoir disposed downstream of the oxygen concentrator; introducingthe therapeutic agent into the oxygen in the infusion tube from thereservoir; utilizing the oxygen in the infusion tube to push thetherapeutic agent to the patch such that the therapeutic agent isdelivered to the patch in combination with the oxygen; allowing thetherapeutic agent to soak on the wound area for a pre-determined periodof time; and removing therapeutic agent from the wound area via vacuumpressure supplied by a vacuum pump.
 2. The method of claim 1, comprisingadjusting a temperature of the therapeutic agent to a temperature thatis above a body temperature of a patient.
 3. The method of claim 1,wherein the introducing comprises opening an infusion solenoid.
 4. Themethod of claim 2, wherein the adjusting is for a duration ofapproximately 10 seconds.
 5. The method of claim 1, wherein the allowingthe therapeutic agent to soak comprises closing a pump solenoid, avacuum vent solenoid, an oxygen vent solenoid, a patch solenoid, and aninfusion solenoid.
 6. The method of claim 1, wherein the allowing thetherapeutic agent to soak is for a duration of approximately 15 minutes.7. The method of claim 1, wherein the removing comprises opening a patchsolenoid and a vacuum vent solenoid.
 8. The method of claim 1, whereinthe removing is for a duration of approximately 30 seconds.
 9. Themethod of claim 1, wherein the utilizing comprises pushing thetherapeutic agent via oxygen supplied by an oxygen concentrator.
 10. Themethod of claim 1, comprising collecting at least one of fluids andmaterials removed from the wound area in an exudate bottle coupled tothe patch.